Ex Parte Polson et al

Patent Trial and Appeal Board

Aug 30, 2016

12132253 (P.T.A.B. Aug. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/132,253 06/03/2008
22827 7590 08/31/2016
DORITY & MANNING, PA
POST OFFICE BOX 1449
GREENVILLE, SC 29602-1449
FIRST NAMED INVENTOR
George A. Polson
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
LZA-12 7351
EXAMINER
GREENE, NAN A
ART UNIT PAPER NUMBER
1619
MAILDATE DELIVERY MODE
08/31/2016 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEORGE A. POLSON, KATHERINE P. ROBERTS,
KHAT KEVIN LOU, and KEVIN N. DINICOLA 1
Appeal2014-008215
Application 12/132,253
Technology Center 1600
Before ERIC B. GRIMES, LORA M. GREEN, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to
compositions and methods for the topical treatment of fungal infections of
the nail. The Examiner rejected the claims as obvious and for failing to
comply with the written description requirement. We have jurisdiction
under 35 U.S.C. § 6(b ). We affirm.
1 Appellants identify the Real Party in Interest as Arch Chemicals, Inc.
(App. Br. 1).
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Application 12/132,253
STATEMENT OF THE CASE
Background
"Fungal infection of the nail, referred to as nail fungus or
onychomycosis, is a common affliction that affects approximately 10 to 14 %
of the population in North America." (Spec. i-f 2). "Typically, fungal
infections are treated by topical application of antifungal agents and/or by
oral administration of the drugs." (Id.). "However, topical treatments of
nail fungal disease so far have been problematic. One problem is that the
thick nail plate prevents topical antifungal agents from permeating the nail
for purposes of reaching the site of the infection." (Id. at i-f 3). "In order to
deliver a sufficient amount of drug into the nail plate, the drug active should
ideally advantageously be water-soluble to an extent sufficient to render the
nail plate permeable by the drug." (Id.) "It is an object of the present
invention to prepare an effective topical pyrithione anti microbial
composition and treatment for fungal infections of the nail." (Id. at i-f 5).
The Claims
Claims 3, 6-11, and 13-20 are on appeal. 2 Claim 16 is illustrative
and reads as follows:
16. A composition for the topical treatment of nail fungus
compnsmg:
(1) from 0.01to2.0 wt% of zinc pyrithione,
(2) from 1.0 to 20 wt% of a solubilizer comprising an
amine, wherein the solubilizer solubilizes the zinc pyrithione,
wherein the solubilized zinc pyrithione penetrate the nail by
forming disulfide linkages through a plurality of cascading
reactions with disulfide linkages of nail keratin;
2 Claims 1, 2, 4, 5, and 12 are cancelled. (App. Br. 24--25).
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Application 12/132,253
(3) from 1.0 to 20 wt% of a potentiator selected from a
zinc source, a copper source, a silver source, and combinations
thereof,
( 4) from 1.0 to 20 wt% of a film former selected from the
group of acrylic copolymers, acrylic polymers, polymers of
methacrylic acid and its esters, cellulose polymers,
nitrocellulose, methyl cellulose, ethyl cellulose, cellulose
acetate, nylon, polyvinyl acetate phthalate, formaldehyde resin,
and combinations thereof;
(5) from 1.0 to 20 wt% of a nail permeation enhancer for
disrupting a tertiary structure of the nail keratin, wherein the
nail permeation enhancer comprises urea or a urea group-
containing compound; and
(6) from 1.0 to 30 wt% of a volatile solvent, all percents
being based upon the total weight of the compositions.
The Issues
A. The Examiner rejected claims 3, 6-11, and 13-20 under 35
U.S.C. § 103(a) as unpatentable over Lawyer3 in view ofHebbom, 4 Rioux5
and Sun6.
B. The Examiner rejected claim 20 under 35 U.S.C § 112, first
paragraph, as failing to comply with the written description requirement.
(Ans. 2). Appellants raise no argument on appeal regarding the rejection
under 35 U.S.C § 112, first paragraph (pre-AIA); therefore, we summarily
affirm the rejection. See 37 C.F.R. § 41.37(c)(l)(iv) (requiring that
"arguments shall explain why the examiner erred as to each ground of
3 US 2007 /0243222 Al, published Oct. 18, 2007.
4 WO 87/02580, published May 7, 1987.
5 WO 2004/057964 Al, published July 15, 2004.
6 U.S. Pat. No. 6,042,845, issued Mar. 28, 2000.
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Application 12/132,253
rejection ... [and that] any arguments or authorities not included in the
appeal brief will be refused consideration by the Board"); see also Ex parte
Frye, 2010 WL 889747 *4 (BPAI 2010) (precedential) ("If an appellant fails
to present arguments on a particular issue----or, more broadly, on a particular
rejection-the Board will not, as a general matter, unilaterally review those
uncontested aspects of the rejection.").
DISCUSSION
The Examiner finds that "a person having ordinary skill in the art
could have combined the zinc pyrithione active agent with a conventional
nail lacquer and included known additives to enhance the efficacy of the
zinc pyrithione active agent, for example, a zinc acetate (potentiator) and a
urea permeation enhancer." (Ans. 9). Furthermore, according to the
Examiner, one of ordinary skill "would have clearly recognized that" the
composition "would have functioned as an antifungal composition functions
when utilized in [a] nail lacquer composition" and would have achieved "an
improved function as an antifungal nail treatment composition by the
inclusion of additives known to enhance the efficacy of the zinc pyrithione
active agent." (Id.). The Examiner finds a "person having ordinary skill in
the art would have recognized that the compositions of zinc pyrithione,
having been taught as a pharmaceutically active nail antifungal agent, would
have predictably functioned as a pharmaceutically active nail antifungal
agent in a nail lacquer composition." (Id. at 10).
The Examiner concludes an ordinarily skilled artisan would view
Rioux as "teachings of enhancing the efficacy of the (zinc) pyrithione
antimicrobial active agents" and, with the combined teachings of Lawyer,
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Hebbom, and Sun regarding antifungal nail treating compositions, "would
have had a reasonable expectation of success in producing the claimed
invention because the simple combination of zinc pyrithione and a known
nail lacquer composition, including suitable efficacy enhancing additives,
would have required no more than an ordinary level of skill in the art" and
would therefore "have beenprimafacie obvious." (Id. at 10-11).
The issue with respect to this rejection is whether the evidence of
record supports the Examiner's rejection of the claims under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Lawyer, Heb born, Rioux,
and Sun.
Findings of Fact (FF)
1. Lawyer discloses a method for treating onychomycosis of a nail of an
animal comprising "topically applying to the nail and surrounding areas an
effective amount of a composition comprising a chemical agent capable of
enhancing iron starvation, e.g., an iron chelating agent, which may include
zinc or a zinc-containing compound alone or in combination with another
zinc compound." (Lawyer i-f 32).
2. Lawyer discloses that "the iron chelating agent is dissolved or
suspended in a pharmacologically acceptable carrier (concentration of
0.0001to100 µg/mL) and the resulting composition is applied topically to
the area to be treated." (Id. at i-f 74).
3. Lawyer discloses "[ z ]inc pyrithione" as a preferable iron chelating
agent useful in treating onychomycosis. (Id. at i-fi-134, 72).
4. Lawyer discloses the use of zinc or other compounds as a potentiator
to enhance iron starvation through transmetallation. Specifically, Lawyer
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teaches "the antifungal activity of iron starvation may be further enhanced
by the addition of zinc." (Id. at i-f 82).
5. Lawyer discloses existing topical antifungal agents include amines
and urea components. (Id. at i-f 21 ).
6. Lawyer discloses film-forming polymers (e.g., cellulose polymers) to
facilitate gelling of the composition and discloses onychomycosis treatment
compositions in the form of a gel, cream, lotion, paste, ointment or solution,
including a nail lacquer. (Id. at i-fi-174, 76, 78-79).
7. Lawyer discloses a volatile solvent (e.g., ethanol) used in the
treatment composition. (Id. at i-fi-175-76, 79).
8. Hebbom teaches cellulose polymers used to form films and facilitate
application to nails (p. 6, 11. 10-12) in a preferred range of 5-15 wt.% (p.
10, Table, row 1) and further teaches an Example comprising 20 wt. %
alcohol solvent. (Hebbom p. 16, line 15).
9. Rioux teaches pyrithione biocides enhanced by zinc metal ions and
organic amines comprising pyrithione, a zinc source, and an organic amine.
(Rioux Abstract).
10. Rioux teaches "[p ]yrithiones are also used as fungicides and
bactericides in personal care products such as anti-dandruff shampoos." (Id.
at 1: 19-20).
11. Rioux discloses compositions comprising pyrithione concentration
ranges from about 0.05% to about 5 wt.%; zinc source concentration ranges
from about 0.005% to about 1 wt.%; and amine concentration ranges from
about 0.5% to about 40 wt. %; (Id. at p. 8, 11. 15-21 ).
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12. Rioux teaches preferred organic amines include ethanolamine and
polyethyleneimine. (Id. at p. 17 11. 15-34, p. 18 lines 1--4, 10).
13. Sun teaches the "nail plate is too thick and too dense for drugs to
penetrate at a practical rate ... it is mainly composed of hard keratin (highly
disulfide-linked) ... [i]n order to deliver a sufficient amount of drug into the
nail plate, the permeability of the nail plate to the drug needs to be
enhanced." (Sun 1 :36-43). "Keratolytic agents, such as urea and salicylic
acid are often used to soften nail plates." (Id. at 1 :57-58).
14. Sun discloses treatment of fungal diseases in nails by application of a
topical composition comprising about 1 to about 50 wt. % of a urea
permeation enhancer, preferably about 5 to about 20 wt% (Id. at 6:30-36;
15:15---65).
15. Sun discloses a pH range of its topical composition is from 2 to 10
and preferably from about 5 to 8 (id. at 6:39--42).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability." Id. at 417.
[A Jn implicit motivation to combine exists not only when
a suggestion may be gleaned from the prior art as a whole, but
when the "improvement" is technology-independent and the
combination of references results in a product or process that is
more desirable, for example because it is stronger, cheaper,
cleaner, faster, lighter, smaller, more durable, or more efficient.
Because the desire to enhance commercial opportunities by
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Application 12/132,253
improving a product or process is universal-and even common-
sensical- . . . there exists in these situations a motivation to
combine prior art references even absent any hint of suggestion
in the references themselves. In such situations, the proper
question is whether the ordinary artisan possesses knowledge
and skills rendering him capable of combining the prior art
references.
Dystar Textilfarben Gmbh & Co. Deutschland KG v. CH Patrick Co., 464
F.3d 1356, 1368 (Fed. Cir. 2006).
Analysis
We agree with the Examiner's conclusions regarding the scope and
teachings of the prior art and adopt them as our Findings of Fact 1-15. The
Examiner persuades us that a person of ordinary skill in the art would have
been motivated to enhance the compositions of Lawyer with the additives
taught by Rioux and Sun to create the claimed antifungal nail lacquer
composition, and could have looked to the guidance from Hebbom and
Rioux in determining the necessary amounts of such components. We
address Appellants' arguments below.
Appellants argue that the appealed claims are patentable over the cited
references because there is "no motivation for combining the teachings of
Lawyer and Sun." (App. Br. 6). Appellants argue that because Lawyer
disclosed a composition that "'significantly improves upon the efficacy of
the conventional treatment ... a person of ordinary skill in the art having
common sense at the time of the invention would not have reasonably
looked to Sun to solve a problem already solved by Lawyer." (Id. at 9).
Appellants cite a nonprecedential holding by our Board, Ex Parte Rinkevich,
Appeal 2007-131 7, May 29, 2007, for the proposition that where a cited
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reference solves a problem at issue in one manner, the examiner should not
impose a rejection based upon a second reference that provides an
alternative solution for the problem because doing so is "impermissibl[ e]
us[ e] [of] the instant claims as a guide or roadmap in formulating the
rejection" that is insufficient to "meet the burden of presenting a prima facie
case of obviousness." (App. Br. 8). Appellants similarly argue against the
Examiner's combination of Lawyer and Rioux because "Lawyer has already
addressed the issue of increasing the efficacy of the compositions disclosed
therein." (Id. at 16).
Appellants raise additional arguments against the Examiner's cited
combination of references: there is no motivation to combine Lawyer and
Sun because Lawyer does not express "any motivation or need for breaking
the disulfide bond in the keratin by utilizing a nail permeation enhancer" (Id.
at 9--10); the "modes of operation of both Lawyer and Sun, and the present
claims, for achieving the desired purpose disclosed therein are
distinguishable such that a person of ordinary skill would not combine the
teachings of Lawyer and Sun in the manner suggested" (Id. at 1 O); there is
no incentive to combine Lawyer and Rioux because Lawyer does not
"disclose a need for a solubilizing an iron chelating agent, such as zinc
pyrithione" or disclose "that the chemical agent penetrates the nail by
forming disulfide linkages through a plurality of cascading reactions with
disulfide linkages of nail keratin." (Id. at 15-16).
We determine that Rinkevich is inapplicable on the instant facts and
Appellants' reading of the decision is contrary to established Federal Circuit
precedent that "evidence of a motivation to combine need not be found in
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Application 12/132,253
the prior art references themselves, but rather may be found in 'the
knowledge of one of ordinary skill in the art or, in some cases, from the
nature of the problem to be solved.'. . . When not from the prior art
references, the 'evidence' of motive will likely consist of an explanation of
the well-known principle or problem-solving strategy to be applied." Dystar
Textilfarben Gmbh & Co. Deutschland KG v. CH Patrick Co., 464 F.3d
1356, 1366 (Fed. Cir. 2006) (emphases in original, quoting In re Dembiczak,
175 F.3d 994, 999 (Fed. Cir. 1999)). See also In re Kerkhoven, 626 F.2d
846, 850 (CCPA 1980) ("It is primafacie obvious to combine two
compositions each of which is taught by the prior art to be useful for the
same purpose, in order to form a third composition which is to be used for
the very same purpose .... [T]he idea of combining them flows logically
from their having been individually taught in the prior art.").
Lawyer's disclosure does not discourage or preclude any further
innovation in the field of topical solutions for treating onychomycosis. Nor
do the individual teachings (or lack thereof) of any reference control whether
multiple references can be combined in an obviousness analysis. The
Supreme Court has held "[i]n determining whether the subject matter of a
patent claim is obvious, neither the particular motivation nor the avowed
purpose of the patentee controls. . . . [A ]ny need or problem known in the
field of endeavor at the time of invention and addressed by the patent can
provide a reason for combining the elements in the manner claimed." KSR
Int'! Co. v. Teleflex Inc., 550 U.S. 398, 419--20 (2007). We conclude that an
ordinarily skilled artisan would be motivated to combine the teachings of
prior art such as Lawyer with other references such as Sun and Rioux to
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create improved fungicidal compositions "logically from their having been
individually taught in the prior art." Kerkoven, 626 F.2d at 850. We further
find the Examiner's application of the references properly applies the
scientific principles they each teach to solve the problem of the need for
improved fungicidal compounds. Dystar, 464 F.3d at 1366.
Appellants further argue the rejection should be reversed because
several of the cited references fail to disclose critical elements of the claimed
compositions. Specifically, Appellants argue Lawyer does not "express a
nail permeation enhancer" or "any motivation or need for breaking the
disulfide bond." (App. Br. 9--10). Likewise, Appellants argue Rioux does
not "disclose the use of the compositions disclosed (in Lawyer) for personal
care applications." (Id. at 16).
Those arguments are unpersuasive as the Examiner's rejection is
based on the combined teachings of Lawyer, Rioux, Sun and Heb born. (See
Ans. 5). Nonobviousness cannot be established by attacking the references
individually when the rejection is predicated upon a combination of prior art
disclosures. In re Merck & Co. Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986);
see also In re Keller, 642 F.2d 413, 426 (CCPA 1981) (finding "one cannot
show nonobviousness by attacking references individually where, as here,
the rejections are based on combinations of references" (citations omitted)).
Thus, whether Lawyer or Rioux individually fails to teach any part of the
compositions disclosed in Lawyer or their use for personal care applications
is not germane to the rationale underlying the rejection. As stated by the
Examiner, Sun teaches that the thickness of the nail plate precludes drug
penetration due to highly disulfide linked keratin, and discloses keratolytic
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agents that break the disulfide bonds including urea for nail softening. (FF
13; Ans. 7-8). Rioux teaches use of pyrithiones as fungicides and
bactericides in personal care products. (FF 10; Ans. 8-9). We are
persuaded that an ordinary artisan, upon reading Lawyer, Sun, and Rioux,
would have reasonably combined the references to arrive at the claimed
invention.
Appellants argue that one of skill in the art would not combine the
teachings of Lawyer and Rioux because "a person of ordinary skill in the art
would recognize that an amine may compete with Lawyer's chelating agent
for the iron and diminish the efficacy of the chelating agent." (App. Br. 16).
Appellants provide no evidence in support of this argument. Appellants'
arguments without more cannot establish nonobviousness. See In re Geisler,
116 F.3d 1465, 1470 (Fed. Cir. 1997) ("[A]ttomey argument [is] not the
kind of factual evidence that is required to rebut a prima facie case of
obviousness").
Appellants next argue that "the combination of Lawyer and Sun fails
to teach or suggest a pH of from about 4.0 to about 7.4, as required by claim
8" and to teach or suggest the elements of claims 16 and 6, from which
claim 8 depends. (App. Br. 10). Appellants concede that Sun discloses a pH
range of from 2 to 10 and preferably from 3 to 8 (id. at 11-12), which
entirely encompasses the claimed range, but argue that the "pH of a
formulation or composition is dependent upon the components present
therein" and "Sun only teaches a pH range of from about 2 to 10 for a
formulation comprising urea and a sulfuydryl-containing amino acid or
derivative thereof." (Reply Br. 5).
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We are not persuaded. Sun discloses a pH range that encompasses the
claimed range. (FF 15). "[W]here there is a range disclosed in the prior art,
and the claimed invention falls within that range, there is a presumption of
obviousness. But the presumption will be rebutted if it can be shown: (1)
That the prior art taught away from the claimed invention, In re Geisler, 116
F.3d 1465, 1471 (Fed. Cir. 1997); or (2) that there are new and unexpected
results relative to the prior art, In re Woodruff, 919 F.2d 1575, 1578 (Fed.
Cir. 1990)." Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322
(Fed. Cir. 2004). Appellants' arguments do not overcome the presumption
of obviousness as they do not address either teaching away or new and
unexpected results.
Appellants argue that the combination of Lawyer and Sun "fails to
teach or suggest a nail permeation enhancer consisting of urea or a urea
group-containing compound, as required by claim 19." (App. Br. 13).
Appellants argue that Sun's composition "contains preferably from about
5% to about 20% by weight of urea and preferably from about 3% to about
20% by weight of the sulfuydryl-containing amino acid or derivative
thereof." Id. According to Appellants, "a person of ordinary skill in the art
would not utilize urea without also utilizing a sulfuydryl containing amino
acid or a derivative thereof' in light of Sun's teachings of the advantages of
the combination as a nail permeation enhancer. Id. at 13-14. Appellants
argue Sun "teaches away from using only urea or a urea group-containing
compound as required by the phrase 'consists of' in claim 19. Id. at 14.
We are not persuaded. "Under the proper legal standard, a reference
will teach away when it suggests that the developments flowing from its
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disclosures are unlikely to produce the objective of the applicant's invention.
A statement that a particular combination is not a preferred embodiment
does not teach away absent clear discouragement of that combination."
Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005)
(citations omitted). Appellants' arguments do not persuade us as the
teachings of Sun do not clearly discourage one of skill in the art from using
urea in a composition for the topical treatment of fungal infections without
also utilizing a sulthydryl containing amino acid or a derivative thereof. To
the contrary, Sun teaches that urea is conventionally used to enhance the
permeability of nails for treatment with drugs (FF 13).
Appellants next argue that the combination of Lawyer and Rioux fails
to disclose the combination of the solubilizer and the potentiator in their
respective amounts as required by claim 16 because the disclosed
embodiments are either outside the claimed range of amine solubilizer with
"no motivation for reducing the amount of organic amine component to the
amount as required by claim 16" (App. Br. 18) or because "a person of skill
in the art would not be motivated to incorporate 0.5% to about 40 wt% of
amine within the formulation of Lawyer" because claim 16 requires 1-20%
of a potentiator, which is "relatively greater than the zinc source as taught"
in Rioux' s embodiment. As stated above, the Examiner persuades us that
the teachings of the cited references provide sufficient motivation to
combine the references absent express teachings in the references
themselves. Dystar Textilfarben Gmbh & Co. Deutschland KG, 464 F .3d at
1366. Furthermore, we find that Rioux's disclosure within the claimed
range of the amine solubilizer is sufficient to render this limitation obvious.
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Determination of the precise claimed range of the multiple components is a
matter of routine experimentation well within the abilities of one of ordinary
skill in the art. "[W]here the general conditions of a claim are disclosed in
the prior art, it is not inventive to discover the optimum or workable ranges
by routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Finally, Applicants argue the combination of Lawyer and Rioux fails
to disclose the nail permeation enhancer of claim 16, and specifically, that
Rioux does not "provide any teaching or suggestion" for utilizing its
disclosed urea-based compounds "as a nail permeation enhancer that
disrupts the tertiary structure of the nail keratin." (App. Br. 19--20). We are
not persuaded as the Examiner cited to Sun's disclosure for the use ofurea-
based compounds in treating onychomycosis, not to Rioux's (Ans. 6), and
we agree with the Examiner that Sun discloses use of urea-based compounds
in treating onychomycosis. (FF 13-14 ).
Conclusion of Law
The evidence of record supports the Examiner's rejection of the
claims under 35 U.S.C. § 103(a) as unpatentable over Lawyer in view of
Hebbom, Rioux and Sun.
SUMMARY
We affirm the rejection of obviousness under 35 U.S.C. § 103(a), and
summarily affirm the rejection under 35 U.S.C. § 112, first paragraph, for
lack of written description.
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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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